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N65d01
EUDAMEDClass I (EU MDR)
Ref N65D01Model Microporous Shoe Cover, PE Coated Non-woven Shoe Cover, Half PE Coated Non-woven Shoe Cover, Nonwoven Shoe Cover Machine Made, Nonwoven Shoe Cover Hand Made,Nonwoven Non-Skid Shoe Cover Machine Made, Nonwoven Non-Skid Shoe Cover Hand Made,
Identity
- Model / Reference
- Microporous Shoe Cover, PE Coated Non-woven Shoe Cover, Half PE Coated Non-woven Shoe Cover, Nonwoven Shoe Cover Machine Made, Nonwoven Shoe Cover Hand Made,Nonwoven Non-Skid Shoe Cover Machine Made, Nonwoven Non-Skid Shoe Cover Hand Made, EUDAMEDN65D01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974424840204 EUDAMED06974424846688 EUDAMED06974424842390 EUDAMED
- Basic UDI-DI
- 697442484L06QH EUDAMED
- EMDN Code
- T0208 SHOE COVERS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
N65d01 by Leboo Healthcare Products Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697442484L06QH | Class I | Active |
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Manufacturer
- Manufacturer
- Leboo Healthcare Products Limited
- EUDAMED SRN
- CN-MF-000008521
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (3)
- EUDAMED ef6c1ac1-f4af-4c2c-93a4-d0b32a42902a 61 fields · synced Oct 6, 2026
- EUDAMED 1e84a6a1-b0d4-4195-b6ea-8500acf4c5d4 61 fields · synced May 19, 2026
- EUDAMED 35cb61f7-0d1e-4280-88c3-ef8c57306d0b 61 fields · synced May 19, 2026